• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K121353
Model WL-2301/2302/2303/2305, WL-2301A, WL-2301B
Device Name MINI PATCH
Original Applicant
WELL-LIFE HEALTHCARE LIMITED
1fl, no.16, lane 454
jungjeng rd.
yunghe city, taipei county,  TW ch
Original Contact chin-chin hsieh
Regulation Number882.5890
Classification Product Code
NUH  
Date Received05/04/2012
Decision Date 09/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-